BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS

    MDR report key: 6208718 · Received December 28, 2016

    Report

    Report Number
    6208718
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 19, 2016
    Manufacturer
    STERIS CORPORATION
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STERIS SURGICAL TABLE MODEL 5085 RT CONTROLLER FAILED WITH THE PATIENT IN THE TILT POSITION. ENGINEERING REPLACED THE CONTROLLER DURING THE OPERATIVE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE SAFELY. THE CONTROLLERS HAVE HAD TO BE REPLACED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858535 STERIS TABLE, OPERATING-ROOM, AC-POWERED FQO STERIS CORPORATION 5085 SRT

    Patients

    Seq Age Sex Outcome Treatment
    1